Treating Dementia with Antipsychotic Drug
Elder Abuse in Nursing Facilities: The Over-Administration of Antipsychotic Drugs to Nursing Home Residents
This report was written by Senior Policy Attorney Toby S. Edelman.
Administering antipsychotic drugs to more than a quarter of a million nursing home residents meets the definition of elder abuse and, left unanswered, is a national scandal.
The Administration on Aging defines a subcategory of elder abuse – “physical abuse” – as “inflicting physical pain or injury on a senior, e.g. slapping, bruising, or restraining by physical or chemical means.”
Antipsychotic Drugs Are Dangerous When Administered to People Who Do Not Need Them.
More than a decade ago, the U.S. Food and Drug Administration (FDA) gave its highest level of warning to the public about antipsychotic medications and warned that older people with dementia who were prescribed these drugs are at greater risk for death and other serious harm. Since then, recommendations of experts repeat, with increasing urgency, that antipsychotic drugs should not be given to older people. In November 2015, the American Geriatrics Society’s evidence-based update of its Beers Criteria for “potentially inappropriate medication use in older adults” stated unequivocally that that antipsychotic medications should be avoided for older people, “except for schizophrenia, bipolar disorder, or short-term use as an antiemetic during chemotherapy.” Citing “increasing evidence of harm associated with antipsychotics and conflicting evidence on their effectiveness in delirium and dementia, the rationale to avoid was modified to ‘avoid antipsychotics for behavioral problems unless nonpharmacological options (e.g., behavioral interventions) have failed or are not possible, and the older adult is threatening substantial harm to self or others [italics in original].’” Thus, there is a very limited category of people for whom the drugs could be appropriate.
Multiple ongoing studies continue to document that antipsychotic drug use is associated with increased risk for falls and fractures, acute kidney injury, myocardial infarction (heart attack), hospitalization, and death, among other poor outcomes suffered by older people who are given antipsychotic drugs. Some of these studies focus, in particular, on older people with dementia who are administered antipsychotic drugs for reasons not approved by the FDA – so-called “off-label” uses.
Over a Quarter of a Million Nursing Home Residents Are Given Antipsychotic Drugs.
Despite the clear, consistent, and ever-growing body of evidence that antipsychotic drugs should not be prescribed for older people, hundreds of thousands of nursing home residents are given these drugs on a regular basis. The Centers for Medicare & Medicaid Services (CMS) reports that, in the first quarter of 2016, information self-reported by nursing facilities indicates that 20.77% of 1,300,222 nursing home residents – 270,056 individuals – took antipsychotic drugs. The overwhelming majority of these residents have not been diagnosed with a psychosis that could possibly support the administration of antipsychotic drugs. Instead, these residents have dementia or are otherwise unable to explain with words what is causing them stress or discomfort.
Why are residents chemically restrained and abused? There are two critical reasons: inadequate staffing levels at nursing facilities and inadequate enforcement of federal standards of care.
Inadequate Nurse Staffing
Too often, nursing facilities use antipsychotic drugs to control residents when they do not have sufficient numbers of nursing staff – professional registered nurses, licensed practical nurses, and certified nursing assistants – to provide direct, hands-on care to residents. In 2012, analyzing nationwide data that it received from the federal government about nurse staffing levels and antipsychotic drug use, the Boston Globe reported “a clear link between the rate of antipsychotic use in a nursing home and its staffing level.” The investigative journalists reported, “Homes that most often used these drugs for conditions not recommended by regulators had fewer registered nurses, who direct care, and nurses’ aides, who provide most of the hands-on care.” Simply stated, in the absence of sufficient numbers of professional and paraprofessional nursing staff, facilities inappropriately use antipsychotic drugs to quiet and control residents.
There is a solution to this form of elder abuse! Improve staffing levels in nursing facilities. Long-standing evidence confirms that nursing facilities employ too few nurses to meet residents’ needs.
Fifteen years ago, a comprehensive Congressionally-mandated national study documented that nursing facilities do not have sufficient nursing staff to meet residents’ needs. The study looked at staffing levels in two ways. An empirical analysis evaluated actual practices in more than 5,000 nursing facilities in 10 states; a time-motion simulation estimated the nurse aide time needed to meet certain key care functions.
The empirical analysis found that 97% of nursing facilities failed to meet one or more nurse staffing standards and 52% failed to meet all of the nurse staffing standards. Below these staffing levels, quality of care was compromised and residents were at risk of harm. The time-motion study estimated that 91% of facilities did not have sufficient nurse aides to meet residents’ needs in five care processes (“1) dressing/grooming independence enhancement, 2) exercise, 3) feeding assistance, 4) changing wet clothes and repositioning residents, 5) providing toileting assistance and repositioning residents”).
Although residents’ needs have increased since the federal government’s staffing study was completed fifteen years ago as sicker people are cared for in SNFs, staffing has not increased sufficiently to meet these needs.
Non-Enforcement of Federal standards of care
A second key reason for the over-administration of antipsychotic drugs to nursing home residents who have dementia is the failure of federal and state government survey agencies to effectively enforce long-standing regulations limiting the use of antipsychotic drugs.
The federal Nursing Home Reform Law sets out the standards of care that nursing facilities must meet in order to participate in, and be eligible for reimbursement under, the Medicare or Medicaid programs, or both. The Law also establishes the survey protocol by which state survey agencies determine facilities’ compliance with federal standards of care and the enforcement actions that may, or, in some instances, must, be imposed when facilities are determined not to be in substantial compliance with the standards. Under the federal nursing home enforcement system, enforcement sanctions are generally imposed only if a facility’s noncompliance is classified as occurring at a “harm” or “immediate jeopardy” level. “No harm” deficiencies lead to no enforcement.
Since 1992, federal regulations implementing the Reform Law have expressly prohibited the use of “unnecessary drugs.” They have also explicitly required that antipsychotic drugs be administered only to treat a resident’s specific medical condition and, even then, use of the drugs is required to be reduced and, if possible, eliminated. Unfortunately, these explicit requirements are rarely enforced.
In cooperation with CMS, the Center for Medicare Advocacy and Lerner Consulting conducted a study of antipsychotic drug deficiencies in seven states. Analyzing all 295 antipsychotic drug deficiencies cited in those states in 2010 and 2011, the study found that 95% of deficiencies were cited at a “no harm” (D or E) level, regardless of the poor outcomes for residents, the total number or proportion of residents affected by deficient practices, and the number of specific federal requirements violated by the facility.
Three states cited a total of 15 harm-level deficiencies, and 11 of these deficiencies were cited by a single state. Four states did not cite a single harm-level antipsychotic drug deficiency in the two-year period.
CMS does not describe enforcement of federal rules about antipsychotic drugs as part of its antipsychotic drug agenda. In a June 3, 2016 report on its five-year old National Partnership to Improve Dementia Care in Nursing Homes, CMS never once mentions the imposition of sanctions as a method of reducing the inappropriate administration of antipsychotic drugs to nursing home residents. Instead, CMS focuses on training, state coalitions, partnerships, awarding a grant to the Eden Alternative for a project entitled “Creating a Culture of Person-Directed Dementia Care,” posting of resources about antipsychotic drugs on the website of Advancing Excellence, publicly reporting antipsychotic drug rates on its website Nursing Home Compare, and developing and testing of a Focused Dementia Care Survey.
 Administration on Aging, “What is elder abuse?” http://www.aoa.gov/AoA_programs/Elder_Rights/EA_Prevention/whatIsEA.aspx/
 In April 2005, the FDA issued “black box” warnings against prescribing atypical antipsychotic drugs for patients with dementia, cautioning that the drugs increased dementia patients’ mortality. FDA, “Public Health Advisory: Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances” (April 11, 2005), http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm05317 In June 2008, the FDA extended its warning to all categories of antipsychotic drugs, conventional as well as atypical, and directly and unequivocally advised health care professionals, “Antipsychotics are not indicated for the treatment of dementia-related psychosis.” FDA, “Information for Healthcare Professionals: Conventional Antipsychotics,” FDA Alert (June 16, 2008), http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124830.htm.
 The American Geriatrics Society 2015 Beers Criteria Update Expert Panel, “American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults,” Journal of the American Geriatrics Society, Vol. 63, No. 11, page 2233, Table 2 (Nov. 2015), http://onlinelibrary.wiley.com/doi/10.1111/jgs.13702/pdf
 Id. 2242.
 Lisa-Ann Fraser, Kuan Liu, Kyla L. Naylor, Y. Joseph Hwang, Stephanie N. Dixon, Salimah Z. Shariff, Amit X. Garg, “Falls and Fractures With Atypical Antipsychotic Medication Use: A Population-Based Cohort Study,” JAMA Intern Med. 2015;175(3):450-452, http://archinte.jamanetwork.com/article.aspx?articleid=2089230.
 Y. Joseph Hwang, Stephanie N. Dixon, Jeffrey P. Reiss, Ron Wald, Chirag R. Parikh, Sonja Gandhi, Salimah Z. Shariff, Neesh Pannu, Danielle M. Nash, Faisal Rehman, Amit X. Garg, “Atypical Antipsychotic Drugs and the Risk for Acute Kidney Injury and Othr Adverse Outcomes in Older Adults: A Population-Based Cohort Study,” Ann Intern Med. 2014; 161(4):242-248, http://archinte.jamanetwork.com/article.aspx?articleid=2089230; http://annals.org/article.aspx?articleid=1897100.
 Zheng-he Yu, Hai-yin Jiang, Li Shao, Yuan-yue Zhou, Hai-yan Shi, Bing Ruan, “Use of Antipsychotics and Risk of Myocardial Infarction: A Systematic Review and Meta-analysis,” British Journal of Clinical Pharmacology (accepted for publication), http://onlinelibrary.wiley.com/doi/10.1111/bcp.12985/pdf.
 Rajender R. Aparasu, Satabdi Chatterjee, Hua Chen, “Risk of Hospitalization and Use of First- Versus Second-Generation Antipsychotics Among Nursing Home Residents,” Psychiatric Services, Vol. 65, Issue No. 6, 781-788 (June 2014), http://ps.psychiatryonline.org/doi/abs/10.1176/appi.ps.201300093
 Donovan T. Maust, Hyungjin Myra Kim, Lisa S. Seyfried, Claire Chiang, Janet Kavanagh, Lori S. Schneider, Helen C. Kales, “Antipsychotics, Other Psychotropics, and the Risk of Death in Patients With Dementia; Number Needed to Harm,” JAMA Psychiatry. 2015; 72(5): 438-445, http://archpsyc.jamanetwork.com/article.aspx?articleid=2203833.
Reports/Minimum-Data-Set-3-0-frequency-report.html [site visited May 19, 2016].
 Kay Lazar and Matt Carroll, “A rampant prescription, a hidden peril,” Boston Globe (April 29, 2012), http://archive.boston.com/news/local/massachusetts/articles/2012/04
 CMS, Report to Congress: Appropriateness of Minimum Nurse Staffing Ratios in Nursing Homes, Phase 1, Vol. I (Winter 2001), http://phinational.org/sites/phinational.org/files/clearinghouse/Phase_I_VOL_I.pdf; Vol II, http://phinational.org/legislation-regulations/report-congress-appropriateness-minimum-nurse-staffing-ratios-nursing-
home-1; Vol. III, http://phinational.org/sites/phinational.org/files/clearinghouse/Phase_I_VOL_III.pdf. CMS, Report to Congress: Appropriateness of Minimum Nurse Staffing Ratios in Nursing Homes Phase II, Vol. I (March 2002), http://phinational.org/sites/phinational.org/files/clearinghouse/PhaseIIVolumeIofIII.pdf; Vol. II, http://phinational.org/sites/phinational.org/files/clearinghouse/PhaseIIVolumeIIofIII.pdf; Vol. III, http://phinational.org/sites/phinational.org/files/clearinghouse/PhaseIIVolumeIIIofIII.pdf.
 CMS, Report to Congress: Appropriateness of Minimum Nurse Staffing Ratios in Nursing Homes Phase II, Vol. II, pages 3-16 and 3-17, http://phinational.org/sites/phinational.org/files/clearinghouse/PhaseIIVolumeIIofIII.pdf.
 Id. 3-19.
 42 U.S.C. §§13958-3(b)-(d), 1396r(b)-(d), Medicare and Medicaid, respectively.
 42 U.S.C. §§1395i-3(g), 1396r(g).
 42 U.S.C. §§1395i-3(h, 1396r(h).
 CMS, Nursing Home Enforcement Reports Through December 31, 2014, page 5, attached to CMS, “Public Release of Nursing Home Enforcement Information Announcement,” S&C: 16-27-NH (June 3, 2016) (Memorandum from David R. Wright, Director, Survey and Certification Group, to State Survey Agency Directors), (CMS confirming that “most enforcement actions are taken in response to deficiency findings at the actual harm and immediate jeopardy levels”), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-27.pdf.
( 42 C.F.R. §483.25(l)(1), Unnecessary drugs, provides:
(l) Unnecessary drugs—
1) General. Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used:
(i) In excessive dose (including duplicate drug therapy); or
(ii) For excessive duration; or
(iii) Without adequate monitoring; or
(iv) Without adequate indications for its use; or
(v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
(vi) Any combinations of the reasons above
 42 C.F.R. §483.25(l)(2) provides:
(2) Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that—
(i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and
(ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.
 “CMA Report: Examining Inappropriate Use of Antipsychotic Drugs in Nursing Facilities,” http://www.medicareadvocacy.org/cma-report-examining-inappropriate-use-of-antipsychotic-drugs-in-nursing-facilities/#.
 CMS, “Update Report on the National Partnership to Improve Dementia Care in Nursing Homes,” S&C: 16-28-NH (June 3, 2016) (Memorandum from David R. Wright, Director, Survey and Certification Group, to State Survey Agency Directors), https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-28.pdf.
This report was written by Senior Policy Attorney Toby S. Edelman.